Pressure Ulcer Clinical Trial
Official title:
Evaluation of the Impact of the Repositioning Schedule Adapted to the Risk of Pressure Ulcer of Patients in Intensive Care Unit
Pressure ulcers represent a major health issue because of their high incidence and their important consequences. There is an important risk of pressure ulcer acquisition for ICU patients with acute organ failure(s). Specific risk factors identified in ICU are immobility, which accentuates the effects of friction and shears, as well as mechanical ventilation and the use of vasopressors. A repositioning schedule is a guideline for pressure ulcer prevention, but repositioning frequency remains unknown. Adaptation of the repositioning schedule to pressure ulcer risk assessment using Braden scale should decrease the emergence of pressure ulcer. This could limit their important consequences for ICU patients which add to their brittle clinical condition (infection, increased length of stay, mortality…).
This is a multicenter randomized controlled cluster, parallel open study. In order to avoid a contamination bias between groups, this trial will be randomized at the center level. This randomization will lead to the formation of 2 groups: a group of control centers (usual care) and a group of interventional centers (repositioning schedule). A visit to set up the study will be carried out before the beginning of the inclusions. During this visit, a training course will be delivered to the caregivers of all the research centers on the risk assessment of pressure ulcers using the Braden scale, the evaluation of the skin condition, the identification of the stages of pressure and their management as well as the collection of data necessary for this study. In addition, the interventional group centers will receive training on the application of the repositioning schedule. The risk assessment for pressure ulcers using the Braden scale will be performed daily in both groups. All patients participating in research with a Braden scale ≤ 17 will benefit from a pressure ulcer prevention mattress. Usual care: Within the control group, repositioning schedule frequencies and positioning will be done according to the habits of the service. The daily collection form present in the room will collect information concerning the care related to the positioning of the patient (length of treatment, frequency of positioning, type of positioning, any adverse events occurring during this care), the evaluation of the patients 'cutaneous status, duration of pressure ulcer care and evaluation of the Braden scale. The possible contraindications to the positioning of the patients will be informed by the doctors on the medical prescription according to the current practice. Repositioning schedule: Within the interventional group the repositioning schedule will be applied according to the risk of pressure ulcer evaluated daily by the Braden scale. A medical prescription, as part of the care, will attest to the absence of absolute contraindication or relative to the procedure of mobilization. Depending on the result of the Braden scale, the repositioning schedule is defined as follows: 6 ≥ Braden ≤ 8: alternate positioning every 2 hours; 9 ≥Braden ≤ 13: alternate positioning every 4 hours; 14 ≥ Braden ≤ 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours. 18 ≥Braden ≤ 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03351049 -
An RCT on Support Surfaces for Pressure Ulcer Prevention
|
N/A | |
Completed |
NCT05112068 -
Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
|
||
Completed |
NCT05575869 -
Evaluation of the Impact of the PRONEtect Education Hub vs. Classic Lecture, on the Competencies of Nursing Students
|
N/A | |
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Completed |
NCT04540822 -
Peripheral Catheter Pressure Ulcer Prevention in Pediatry : Use of Compresses Versus Standard Care
|
N/A | |
Terminated |
NCT05234632 -
Study to Evaluate the PICO 14 Negative Pressure Wound Therapy System in the Management of Acute and Chronic Wounds
|
N/A | |
Completed |
NCT02092870 -
Adipose Derived Regenerative Cellular Therapy of Chronic Wounds
|
Phase 2 | |
Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
Completed |
NCT01438541 -
A Multi-centre Evaluation of the Performance of Window Dressings on Subjects With High Risk Pressure Ulceration
|
Phase 4 | |
Completed |
NCT00365430 -
SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes
|
N/A | |
Completed |
NCT04251897 -
Novel Support Surface to Alleviate Pressure Ulcer
|
N/A | |
Completed |
NCT03391310 -
Use of Honey for Pressure Ulcers in Critically Ill Children
|
N/A | |
Recruiting |
NCT04559165 -
Efficacy and Safety of Sericin and Chitosan Cream for Preventing and Limiting the Progressive of Pressure Sore
|
N/A | |
Completed |
NCT05646121 -
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds
|
||
Not yet recruiting |
NCT06421454 -
Clinical Trial for the Evaluation of Melatonin in the Treatment of Pressure Ulcers
|
N/A | |
Terminated |
NCT05547191 -
Evaluate Efficacy and Safety of ChloraSolv When Treating Pressure Ulcers in Need of Debridement
|
N/A | |
Completed |
NCT05458050 -
An Investigation to Identify Subjects Admitted to Hospital With an Increased Risk of Developing Pressure Ulcers
|
N/A | |
Active, not recruiting |
NCT03048357 -
Effectiveness of Freedom Bed Compared to Manual Turning in Prevention of Pressure Injuries in Persons With Limited Mobility Due to Traumatic Brain Injury and/or Spinal Cord Injury.
|
N/A | |
Completed |
NCT06025370 -
Pressures During Prone Positions in Healthy Volunteers
|
N/A | |
Recruiting |
NCT05033470 -
A Multicentre Prospective Study Evaluating an Off-loading Mattress Overlay System in Healing of Stage 3 Pressure Ulcers
|
N/A |